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Comment by RedCardRef | Hacker News Reader

Recently watched the Netflix docu series on this, J&J claimed that cyanide was not present in the factory, so there is no way the pills could have been contaminated at the factory.

Then later on one of the doctors asked J&J if a test for cyanide is done for each batch in QA at the factory. J&J said yes, each batch was tested for the presence of cyanide.

The doctor then asked, "Why were they testing for it(cyanide)?", kinda blew my mind. Implying that J&J knew cyanide contamination was a possibility at the factory itself.

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This is my brother's job, testing for contaminants. He says it can be very boring. For example, they always test for lead, and it's always negative. But it's a necessary precaution when you're making medicine.

This.

I think people don't really understand the requirements you need to meet to get and maintain FDA clearance. I think even under the current administration, you still could have an obligation to do that testing.

That’s all true when the medicine is made here. More and more of every day medicine these days is made in countries with fewer safety regulations like India and China. FDA may inspect them from to time but they have no jurisdiction to actually do anything about violations.

They can stop the product being sold in the USA, which is usually a big deal.

FDA does have jurisdiction. They may prevent imports from manufacturers who violate FDA regs.

Where it is made does not change the rules.

https://www.fda.gov/industry/import-program/actions-enforcem...

But, how is strong is the enforcement regime for labs outside the US?

Why is that strange? Cyanide seems like an obvious thing to test for at scale. Safety engineering doesn't say 'that doesn't seem likely even though it's dangerous and easy to control for so I'll not handle the scenario'. It says, 'anything unsafe should be mitigated with the right cost-benefit analysis applied for the scenario'. Testing for cyanide makes sense regardless of whether it's in the factory.

I really don’t know, but could there be 100 other substances as dangerous and easy to mix/administer as cyanide? There must be some cut off since you can’t test for everything. I’d be interested to know what that test matrix/decision document looks like.

Cyanide is found as an impurity from both natural sources and as a byproduct during the manufacturing process, a lot like lead. So it's common enough to warrant the expense of testing

I would expect a broad spectrum quality test, of which cyanide would be one of the components tested for.

I don't work in pharma but I work in medical electronics, and sometimes you just have to perform random unrelated testing because the standards say so, even if it technically doesn't apply to your product

What was the answer?

I can understand why it might seem suspicious, but I’d also hope that (non-exotic?) substances capable of killing at doses small enough to fit in a Tylenol pill would be in their test matrix.

Cyanide is really simple and can easily be a side product of many organic chemistry reactions, testing for it is just obvious. The ion is just one carbon and one nitrogen which can combine with many different things to make many poisonous salts. Testing for it isn't suspicious and there was very strong evidence that it wasn't a factory mistake.

> kinda blew my mind

Cyanide occurs naturally in some fruit seeds and can be produced by some fungi + algae. So if any of those are things that could end up getting into the production inputs (even in small amounts), it would definitely be worth the effort to test. Even if that's not the case, contamination from other sources inside the factory don't seem terribly off the wall either.

Also if the testing isn't especially hard, complicated or expensive. I see no point to not do it. Specially when contamination is possible due to non-intentional reasons.

> "Why were they testing for it(cyanide)?

Precursor contamination, sabotage, etc. Lots of potential innocent reasons.

It is good that they check, imagine Sigma-Aldrich doing a mistake between two products, or a product accidentally contaminated during manufacture, considering the large amount of things they produce it is not impossible

What’s more worrying isn’t that they tested—it’s that the existence of the test feels like a smoking gun. That says more about our broken trust in institutions than anything else.

It says more about the nature of pharmaceutical manufacturing than anything. We often need to screen for impurities, and cyanide is a pretty common one.

I know some companies use spectroscopy (often raman) to scan select pills/capsules/vials to ensure there aren't any contaminants and to ensure the content is uniform throughout the pill rather than concentrated in one part.

Which is more a showcase of our manufacturing ignorance than it is a smoking gun.

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